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ANTI-CD30 (BER-H2) MOUSE MONOCLONAL PRIMARY ANTIB (2015-08-05)
- Starting date:
- August 5, 2015
- Posting date:
- September 1, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-54860
Affected Products
- ANTI-CD30 (BER-H2) MOUSE MONOCLONAL PRIMARY ANTIB
Reason
A slight decrease of the staining intensity and percent positive cells was observed. No cases demonstrating complete negative (false negative results) were observed. The investigation results support that the expiration date for the affected lot numbers should be set to 18 months from the date of manufacture instead of the currently marked 24 months.
Affected products
A. ANTI-CD30 (BER-H2) MOUSE MONOCLONAL PRIMARY ANTIB
Lot or serial number
- D09123
- E00209
- E03668
- E05896
Model or catalog number
- 790-4858
Companies
- Manufacturer
-
Roche Diagnostics Gmbh
Sandhoferstrasse 116
Mannheim
68305
GERMANY